Find Principal software development Jobs in Dublin, D

Senior Regulatory Affairs Officer (12 Month FTC)
Viatris —Northern Cross, County Dublin
- Full-time
- Bachelor's degree
- Time management
Senior Business Analyst
Codec —Dublin, County Dublin
- Full-time
- Hybrid work
- Azure
- Oracle
- Bachelor's degree
Quick apply
Principal / Lead Geotechnical Engineer
PM Group —Dublin, County Dublin
- Master's degree
- Analysis skills
- Bachelor's degree
Senior Software Developer
Creditsafe —Dublin, County Dublin
- Full-time
- Hybrid work
- AWS
- Communication skills
- Python
- Annual leave
Principal Statistical Programmer
IQVIA —Dublin, County Dublin
- Full-time
- Remote
- Computer Science
- Bachelor's degree
- Quality control
- Work from home
Lead DevOps Engineer
Elwood Roberts —Dublin, County Dublin
- €500–€600 a day
- Full-time
- DevOps
- Java
- Python
Quick apply
Document Controller- Construction Projects
Echelon DC —Dublin, County Dublin
- Full-time
- Microsoft Word
- AutoCAD
- Microsoft Excel
Quick apply
Principal Data Scientist
iCims —DUBLIN 2, County Dublin
- Full-time
- Computer Science
- Research
- Master's degree
- Annual leave
- Life insurance
Principal Geotechnical Engineer
SLR Consulting —Dublin, County Dublin
- Full-time
- CAD
- Project management
- Bachelor's degree
- Annual leave
- Life insurance
Principal/Senior Railway Permanent Way Engineers
Roughan & O'Donovan —Dublin, County Dublin
- English
- Analysis skills
- Project management
Junior Programme Controller
Turner & Townsend —Dublin, County Dublin
- Full-time
- Hybrid work
- Project management
- No degree
- SharePoint
- Annual leave
Quick apply
Staff Site Reliability Engineer
Replit —Dublin, County Dublin
- Full-time
- Remote
- Mentoring
- Communication skills
- Python
- Life insurance
Senior Manager, Architecture & Components
Bristol-Myers Squibb —Dublin, County Dublin
- Full-time
- Microsoft Excel
- Azure
- Computer Science
9d
Staff Engineer, Site Reliability
LearnUpon —Dublin, County Dublin
- On call
- AWS
- AI
- Annual leave
Head of Department - Digital Engineering
Murphy Geospatial —Dublin, County Dublin
- Full-time
- Hybrid work
- Business development
- Leadership
- Gym membership
Quick apply
Principal Engineer, Firmware Engineering
Analog Devices —Glasnevin, County Dublin
- Full-time
- System design
- Master's degree
- C++
Document Controller
Turner & Townsend —Dublin, County Dublin
- Full-time
- Hybrid work
- Project management
- SharePoint
- Communication skills
- Annual leave
Quick apply
Monitoring Surveyor
Murphy Geospatial —Dublin, County Dublin
- Microsoft Word
- AutoCAD
- Microsoft Excel
- Gym membership
Quick apply
Principal Geotechnical Engineer
Cicad —Dublin, County Dublin
- Employee assistance program
6d
Engineering Manager - Pay
Phorest —DUBLIN 1, County Dublin
- Remote
- Computer Science
- System design
- Java
- Employee assistance program
Quick apply

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Senior Regulatory Affairs Officer (12 Month FTC)

Viatris -
Northern Cross, County Dublin

Apply Now

Job details

Full-time

Qualifications

Bachelor's degree
Time management

Full job description

McDermott Laboratories Limited

Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases.

We have been included on number of award lists that demonstrate the impact we are making.

Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.

For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

The Role & What You Will Be Doing

Obtain and maintain marketing authorisations for products in designated EU territories (internal and 3rd Party / BD). Perform any other regulatory activities as required by company strategy.

Every day, we rise to the challenge to make a difference and here’s how the Senior Regulatory Affairs Officer role will make an impact:

Ensure suitable dossiers (marketing authorisation applications / post-approval submissions) are prepared and dispatched on-time according to agreed company procedures and objectives. Review data intended for submission and advise regarding any deficiencies or issues.
Ensure on-time submissions for all safety related changes for assigned projects.
Ensure databases and systems (including D2, GLAMS, MyPortfolio and TrackWise) are updated in-line with current SOPs and up-to-date information is available for all assigned products.
Ensure SPPs for all assigned projects are maintained in-line with current SOPs and guidance.
Liaise with 3rd parties (where required) to establish effective communication and relationships in order to progress regulatory activities.
Liaise closely with Business Development (where required), Regulatory Science, Pharmacovigilance, Product Launch, Artwork, Supply Chain and Quality colleagues to ensure alignment in all initiatives.
Prepare regulatory strategies (including advising of the regulatory requirements) for new marketing authorisation applications / post-approval submissions.
Be actively involved in due diligence activities including evaluation of regulatory strategy and launch timelines, evaluation of risks and regulatory costs.
Advise management of the status and progress of assigned projects identifying potential problems or delays, and possible solutions, as they occur and maintain a current status report for these projects.
Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities) and use this information to optimise departmental procedures and processes and to ensure Health Authority requirements and Regulatory Compliance are maintained.
Embrace the One Team approach across all Regional Submission Teams by ensuring
consolidation of worksharing activities in line with Senior Management guidance, for example increased sharing of expertise and knowledge, combined meetings and collaboration on initiatives and working groups.
Support the Line Manager by participating in project teams to support departmental initiatives.
Provide mentoring and training to (Associate) Regulatory Officers and/or (Senior) Regulatory Assistants as directed by Line Manager.
On an ad hoc basis, carry out additional tasks on behalf of Principal Registration Officer/(Senior) Regulatory Manager.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

Bachelor's degree or equivalent in Science/Technology/ Pharmacy
Experience In Regulatory/Quality/R&D
Capable of understanding health authority expectations for pharmaceutical types for a specified region.
Strong demonstrable capabilities in the use of software applications.
Must possess organization skills, time management skills and attention to detail.

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Some of our benefits include the following on top of a competitive salary:

Excellent career progression opportunities
Work-life balance initiatives
Bonus scheme
Health insurance
Pension

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

Apply Now

Refine Your Search

principal software development jobs in dublin, d

Senior Regulatory Affairs Officer (12 Month FTC)

Senior Business Analyst

Principal / Lead Geotechnical Engineer

Senior Software Developer

Principal Statistical Programmer

Lead DevOps Engineer

Document Controller- Construction Projects

Principal Data Scientist

Principal Geotechnical Engineer

Principal/Senior Railway Permanent Way Engineers

Junior Programme Controller

Staff Site Reliability Engineer

Senior Manager, Architecture & Components

Staff Engineer, Site Reliability

Head of Department - Digital Engineering

Principal Engineer, Firmware Engineering

Document Controller

Monitoring Surveyor

Principal Geotechnical Engineer

Engineering Manager - Pay

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